What are the key risks if the trial fails to meet its endpoints?

Key Risks if ADDRESS‑LC Misses Its Primary Endpoints

1. Fundamental downside pressure – BioVie’s valuation is still heavily premised on the successful demonstration of bezisterim’s efficacy in Long COVID‑related fatigue and cognitive impairment. A failure to hit the primary fatigue or cognition endpoints would strip away the core growth catalyst, forcing the market to re‑price the company on the basis of its existing pipeline (mainly the BIVV‑101 ALS program) and cash‑burn profile. With ~US $150 M of cash on hand and a burn rate of ~US $30 M/quarter, the balance sheet would look increasingly strained, prompting concerns over the need for additional capital and potential dilution.

2. Technical fallout – The stock is currently trading in a relatively tight range around the 52‑week low, reflecting the “wait‑for‑data” premium. A miss would likely trigger a sharp break below the recent support zone (≈ $1.20) and could open a down‑trend channel, inviting short‑covering and stop‑loss hunts. Momentum indicators (RSI still in the 40s) would turn bearish, and the MACD histogram would cross into negative territory, amplifying the sell‑off.

3. Broader market and partnership risk – The Long COVID space is still nascent, and a negative read on a high‑visibility Phase 2 trial could dampen investor enthusiasm for other emerging‑infection‑syndrome assets, eroding sector‑wide sentiment. Moreover, any existing or prospective licensing deals (e.g., with larger pharma partners) would be jeopardized, as those agreements often hinge on “positive Phase 2 data.” The loss of a potential out‑licensing premium would further compress BioVie’s valuation.

Trading Implication

If the trial’s data are released and fall short of the predefined fatigue or cognitive endpoints, expect a 30‑45 % downside from current levels, with the next technical support around the $1.00‑$1.05 band. Short‑position entry could be considered on a break below $1.20 with a stop placed just above the $1.30‑$1.35 resistance (to protect against a data‑positive bounce). Conversely, any upside from a modest efficacy signal would likely be short‑lived; therefore, a tight profit‑target on any bounce is advisable. In the meantime, monitor cash‑runway updates and any statements from the company about pipeline diversification, as those will be the secondary drivers of price stability in a post‑miss scenario.